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Proudly presents Intercept  Drugs of Abuse “Laboratory Confidence, Oral Fluid Convenience” OraSure Technologies, Inc. diagnostic solutions for the new.

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Presentation on theme: "Proudly presents Intercept  Drugs of Abuse “Laboratory Confidence, Oral Fluid Convenience” OraSure Technologies, Inc. diagnostic solutions for the new."— Presentation transcript:

1 Proudly presents Intercept  Drugs of Abuse “Laboratory Confidence, Oral Fluid Convenience” OraSure Technologies, Inc. diagnostic solutions for the new millennium

2  A publicly traded, diagnostic company in business for over 12 years (OSUR, NASDAQ)  Formed by a merger of STC Technologies and Epitope, Inc. 9/2000  A fully integrated R&D, manufacturing and sales organization with ~200 employees  Mission to become the world’s leading oral fluid diagnostic company OraSure Technologies is...

3 The ease of oral fluid collection combined with OTI’s Microplate EIA screening kits....with AUTOMATION to fit any size laboratory OraSure’s Intercept DOA Products The Solution...

4  Easy to administer  2 - minute, observed collection/difficult to adulterate  Provides evidence of recent drug exposure  Preserves donor/ collector dignity  Laboratory testing for NIDA-5 and more…  Next day reporting (varies by lab)  Cost effective automation  Convenience of storing OF samples Features & Benefits of Oral Fluid Collection and Testing

5 Time of collection reduced by 50% Eliminates gender issues Eliminate embarrassment with urine Reduces bathroom/maintenance needs Lab-based screening/confirmation  Lowers collection costs  Reduce/reallocate staffing  Greater dignity (staff & client)  Reduces costs  Same lab quality you expect Oral Fluid Features & Benefits

6  Oral fluid testing identifies recent drug usage that can be missed by urine testing.  Window of detection is 1-3 days, while urine may detect some drugs for a longer period. Oral Fluid versus Urine Testing

7  Amphetamine Specific  Barbiturates  Benzodiazepines  Cannabinoids (THC)  Cocaine  Methadone  Methamphetamine  Opiates  Phencyclidine(PCP)  Human IgG Intercept Micro-Plate DOA Menu

8 OTIDTAB  Amphetamine Specific100ng/mLn/a  Barbiturates20ng/mLn/a  Benzodiazepines1ng/mLn/a  Cannabinoids (THC)1ng/mL4ng/mL  Cocaine Metabolite5ng/mL20ng/mL  Methadone5ng/mLn/a  Methamphetamine40ng/mL50ng/mL  Opiates10ng/mL40ng/mL  Phencyclidine(PCP)1ng/mL10ng/mL Intercept Assay Screening Cutoff’s

9 LOD ng/mL Amphetamine Specific (d-amphetamine)25.5 Bariturates (secobarbital)8.2 Benzodiazepines (nordiazepam)0.181 Cannabinoids (  9 THC)0.37 Cocaine Metabolite (BE)1.5 IgG (human IgG)1.5 Methadone (methadone)0.52 Methamphetamine (d-methamphetamine)8.0 Opiates (morphine)1.4 Phencyclidine (PCP)0.49 Intercept Assay LOD’s

10 AssaySignificant Cross-Reactivity Amphetamine SpecificD-amphetamine 100% MDA 49% Mephentermine15% BarbituratesAllobarbital24% Amobarbital43% Aprobarbital29% Butabarbital 185% Butalbital109% Pentobarbital68% Phenobarbital50% Secobarbital 100% *  10%Talbutal170% Cross-Reactivity Profiles*

11 AssaySignificant Cross-Reactivity Benzodiazepines (nordiaz.)Alprazolam151% Chlorazepate70% Desalkylflurazepam17% Diazepam135% Estazolam130% Flurazepam49%  -Hydroxyalprazolam10% Medazepam17% Midazolam49% Nitrazepam39% Nordiazepam100% Prazepam107% Temazepam55% Triazolam26% *  10%  -Hydroxytriazolam15% Cross-Reactivity Profiles*

12 AssaySignificant Cross-Reactivity Cannabinoids  9 -THC100%  8 -THC105% 11-nor 9-Carboxy  9-THC279% 11-Hydroxy-  9 -THC174% Cannabinol15% Cocaine Metab.Benzoylecgonine100% Cocaine64% Cocaethylene200% *  10% Cross-Reactivity Profiles*

13 AssaySignificant Cross-Reactivity MethadoneLAAM18% Methadone100% MethamphetamineD-Methamphetamine100% Fenfluramine26% MDMA288% *  10% Cross-Reactivity Profiles*

14 AssaySignificant Cross-Reactivity Opiates6-Acetylmorphine65% 6-Acetylcodeine>100% Codeine>100% Diacetylmorphine43% Dihydrocodeine185% Hydrocodone76% Hydromorphone20% Morphine100% PCPPhencyclidine100% *  10% Cross-Reactivity Profiles*

15 Q: Why does the collector have a salty taste? A: Intercept uses very low levels of common salts on the pad to enhance collection of oral fluids. Q: What type of gelatin is used on the pad and are there any religious issues? A: Intercept uses kosher gelatin; also, Jewish religion does allow for the intake of certain materials like this for medical purposes. Q: Is there anything that has been shown to interfere with the collection or tests? A: A variety of materials have been studied in all assays with minimal effect on results. While we have seen no common agents being used to adulterate OF testing, users should always closely monitor collections and react to any suspicious behavior. Q & A on the Collection Process

16 Q: How important is the 10 minute wait period prior to collection? A: The oral cavity tends to clear itself about every 10 minutes and waiting this time is a precaution to address the occasional argument that a result was positive because of something consumed prior to collection. Q: What happens if the collection goes over 2 minutes?9 A: A 2-5 minute time period is an acceptable window for collection without any impact on test results, however, always collect at least 2 minutes to avoid an inadequate sample. Q: How do you know that an adequate sample was taken? A: The laboratory uses the IgG test kit which tests for human IgG. If the IgG level falls below 0.5 ng/mL, the sample is reported as being inadequate. Q & A on the Collection Process

17 Oral Fluid vs Urine Test Statistics (Positive Rates) OF Urine Non-DOT Urine DOT Amp0.3%0.4%0.3% Coc1.2%0.8%0.6% THC2.8%2.9%1.4% Opi0.3%0.2%0.2% PCP0.0%0.0%0.0% * Data represents oral fluid specimens tested at LabOne, Inc., Lenexa, KS (Jan 1 – Sept 30, 2001) Selected Data on Intercept

18 Q: Does the Methadone assay cross-react with methadone metabolites? A: This assay does not cross-react greatly with metabolites, however, testing of these classes is more common in urine testing where methadone spiking/adulteration is more common. Q: How similar are the windows of detection for urine versus oral fluids? A: The WOD for most drugs are very similar for rine and OF, with the exception of THC, which tends to be somewhat shorter in OF. Q: What is the turn-around time on negatives/positives from the lab? A: 24 hours for negatives and 48-72 hours for confirms (labs may vary; check with each lab for their specific turnaround time). Q & A on Assays & Lab Services

19 Q: How quickly are orders processed for new collection kits? A: An ordering system may be set up so that inventory is always on- hand; if needed, kits can be sent overnight. Q: How do we get our data? A: Data can be provided by fax, electronic or mail. Q: How will we be trained? A: The laboratory and OraSure Technologies will provide the training for your staff. It is best to train a group of staff members in one location or several selected locations who then become the trainers for each site. Q: Can confirmations be performed on the original sample? A: Yes. This is not the case with all other OF tests on the market. Q: Can the lab provide expert testimony? If so, at what cost? A: Yes. Both the lab and OraSure can provide experts if needed. Costs will vary with travel location and duration. Q & A on Assays & Lab Services

20 Q: Do the assays pick up Ecstacy? A: Yes. The Intercept Methamphetamine assay has a very high cross- reactivity with MDMA. Q: Will the Opiates assay pick up oxycodone? A: Use of the standard 10ng cutoff will not lead to high cross- reactivity with oxycodone but the lab can run a 1ng application which will pick up oxycodone positives. Q: Does the Benzodiazepine assay react with many of the low dose drugs in this class? A: Yes. The assay does cross-react with the standard classes as well as many of the low dose drugs in this class (see insert for specific data). Q & A on Assays & Lab Services

21  More sensitive to patient needs by being less embarrassing and easier for patients to provide an oral fluid specimen compared to urine specimen.  Security officers and other team members report that it is “safer” and “cleaner” to handle an oral fluid specimen as opposed to urine specimens.  Difficult to adulterate as team members can directly observe the entire collection process.  More than one patient can be tested at a time.  Facility seemed cleaner as the usual clutter of paper towels and/or cups were not present in the bathrooms.  Eliminates many of the reasons previously offered by patients not providing a urine sample for drug testing, such as, can’t urinate, I just went, menstruation, etc. * ARTC = Addiction Research & Treatment Corp (Exec. Director, Beny J. Primm, M.D.) Observations from ARTC, NYC

22  Officers were always able to collect OF samples from their clients (no male/female gender issues), providing more direct and candid interactions and outcomes.  OF collection took about ½ the time to collect compared to that of urine resulting in labor savings and more quality time available for Officers and clients to interact.  Both Officers and clients reported a greater degree of dignity in the collection process.  OF collection eliminates the occurrence of “shy bladder”.  Some Officers did not feel they need to wear latex gloves with OF samples providing additional cost savings.  OF testing picks up more recent drug use than urine, eliminating the argument that screen positives are due to past positive events. * Statements from Mr. Wayne Cain, Community Corrections Supervisor Observations from Washington DOC

23 Rely on OraSure’s Oral Fluid Drugs of Abuse Testing Products COMPLETE SYSTEMS & SOLUTIONS! For Results...

24 For more information, please contact: Drug Testing Pacific Ltd Tel. (0)9 434 4669 Fax (0)9 434 4669 Email: email@drugtesting.net.nz or visit us on our web site at www.drugtesting.net.nz 090401 DTP thanks you for your time and interest...


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